Table 4.
Potential off-label use of aclidinium and aclidinium/formoterol
| Evaluation of indication | CPRD, UK, n (%) a | National Health Databases, Denmark, n (%) b | GePaRD, Germany, n (%) c | |||
|---|---|---|---|---|---|---|
| Aclidinium (N = 4871) d | Aclidinium/ formoterol (N = 2153) e | Aclidinium (N = 2836) d | Aclidinium/formoterol (N = 2586) e | Aclidinium (N = 9961) d | Aclidinium/formoterol (N = 10,069) e | |
| On-label use | 4333 (89.0) | 1949 (90.5) | 1589 (56.0) | 1493 (57.7) | 8706 (87.4) | 9346 (92.8) |
| COPD only | 2526 (51.9) | 1364 (63.4) | 1090 (38.4) | 1204 (46.6) | 5790 (58.1) | 6655 (66.1) |
| COPD and asthma and age < 40 years | 16 (0.3) | 3 (0.1) | 11 (0.4) | < 5 (NR) g | 81 (0.8) | 56 (0.6) |
| COPD and asthma and age ≥ 40 years | 1791 (36.8) | 582 (27.0) | 488 (17.2) | 288 (11.1) | 2835 (28.5) | 2635 (26.2) |
| Off-label use f | 244 (5.0) | 68 (3.2) | 253 (8.9) | 78 (3.0) | 540 (5.4) | 259 (2.6) |
| Children, age < 18 years | 0 (0.0) | 0 (0.0) | 5 (0.2) | 0 (0.0) | 7 (0.1) | < 5 (NR)g |
| Asthma only | 244 (5.0) | 68 (3.2) | 250 (8.8) | 78 (3.0) | 535 (5.4) | 257 (2.6) |
| Unknown indication | 294 (6.0) | 136 (6.3) | 994 (35.0) | 1015 (39.2) | 715 (7.2) | 464 (4.6) |
| Lung cancer f | 20 (0.4) | 7 (0.3) | 19 (0.7) | 24 (0.9) | 16 (0.2) | 19 (0.2) |
| Other respiratory conditions f | 275 (5.6) | 123 (5.7) | 78 (2.8) | 87 (3.4) | 16 (0.2) | 8 (0.1) |
| Bronchiectasis | 12 (0.2) | 13 (0.6) | 10 (0.4) | 8 (0.3) | < 5 (NR)g | < 5 (NR)g |
| Lung diseases caused by external agents | 6 (0.1) | < 5 (NR)g | 9 (0.3) | 7 (0.3) | 7 (0.1) | 5 (< 0.1) |
| Other respiratory disease | 274 (5.6) | 121 (5.6) | 66 (2.3) | 78 (3.0) | 5 (0.1) | 0 (0.0) |
| No lung cancer or other respiratory conditions | 19 (0.4) | 11 (0.5) | 916 (32.3) | 922 (35.7) | 683 (6.9) | 437 (4.3) |
COPD chronic obstructive pulmonary disease, CPRD Clinical Practice Research Datalink, GePaRD German Pharmacoepidemiological Research Database, NR not reported, UK United Kingdom
aCPRD data on new users of study medications identified from 1 January 2015 through 31 December 2017
bNational Health Databases data on new users of study medications identified from 4 March 2015 through 31 December 2017
cGePaRD data on new users of study medications identified from 1 February 2015 through 31 December 2015
dAclidinium comprises aclidinium monotherapy and the non-fixed-dose combination of aclidinium bromide plus formoterol
eFixed-dose combination of aclidinium bromide and formoterol
fPatients could be classified in more than one category
gAll non-zero small cell counts are reported as < 5, and corresponding percentages are not reported due to privacy policies